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Simone Mitchell

Partner
+61.2.9513.2428
Fax +61.2.9513.2399

Dr. Mitchell advises a broad range of companies on intellectual property (including patents, copyright, trademarks, designs and plant breeder's rights) as well as regulatory and compliance issues.

Dr. Mitchell has significant experience representing clients in intellectual property disputes. She has acted for companies representing diverse industries including pharmaceutical, medical device, biotechnology, technology, consumer goods, mining and construction. Her work also covers intellectual property management strategies, including the exploitation, commercialisation, management and protection of intellectual property rights.

Dr. Mitchell's experience encompasses advising on the regulatory framework for therapeutic goods, cosmetics, chemicals and foods in Australia. In particular, she has advised a number of the world's largest life sciences companies on issues arising in the context of research and development, clinical trials, GMP, pricing and reimbursement, compliance with industry codes, advertising complaints and disputes with regulators.

Professional Background

Dr. Mitchell has been practicing for 14 years in the area of intellectual property litigation and advising and acting in contentious matters for life sciences clients. Prior to that, Dr. Mitchell practised as a veterinary surgeon.

Prior to joining K&L Gates, Dr. Mitchell co-led the life sciences practice across the Asia Pacific region at one of the world's largest law firms.

Achievements

  • Listed as a Notable Practitioner in Chambers & Partners (Life Sciences: Asia Pacific), 2016, 2015 and 2014 
  • Features in Managing Intellectual Property's IP Stars Handbook for Patent Litigation, 2015

Professional/Civic Activities

  • Law Society of New South Wales member 
  • Intellectual Property Society of Australia and New Zealand member
  • AusBiotech member

Additional Information

Dr. Mitchell has written extensively about intellectual property law, particularly with respect to patent protection and enforcement, and pharmaceuticals, biotechnology and regulatory matters. She co-authored the Australian chapter of the Practical Law Company's Multi-Jurisdictional Guide: Life Sciences (2012- 2016) as well as Marketing and Distribution of Drugs (2015).

Intellectual Property Litigation

  • Acting in three sets of patent proceedings relating to Servier's pharmaceutical product, Conversyl® (perindopril).
  • Acting in preliminary injunction proceedings in relation to threatening infringement of a patent directed to its Exelon® (rivastigmine) product.
  • Acting in patent revocation proceedings concerning its Neulasta® (pegfilgrastim) product.
  • Acting for Razor Industries, a mining product company, in the first Federal Court of Australia proceedings to consider the eligibility of a third party to exploit an invention pursuant to section 223(9) of the Patents Act 1990 (Cth)
  • Acting for Boral in patent infringement proceedings concerning a patent directed at load bearing masonry bricks.
  • Acting for Concur, travel management company in defence of allegations that it infringed a business method patent by use of its group travel management software. 
  • Acting for Bitech Engineering, a heater manufacturer, in patent infringement proceedings involving a patent claiming a device for simulating flames in electric and gas fired room heaters.
  • Acting for a manufacturer of heaters in patent infringement proceedings involving a patent claiming a device for simulating flames in electric and gas fired room heaters. 
  • Advising in a multi-jurisdictional patent dispute relating to a patent claiming a process of dying fabric.
  • Acting for Solahart in trade mark infringement and misleading and deceptive conduct proceedings relating to the Solahart® trade mark.
  • Acting for a company providing product photography and content services, in defence of allegations that it had infringed copyright by use of certain images on its platform. 
  • Acting for Mars Foods in relation to a designs dispute arising from the use of a certain shaped doy pouch for its range of Masterfoods sauces and gravies.
  • Acting for Newell Rubbermaid in relation to a patent, design and trade mark dispute arising from a competitor marketing products which were compatible with a range of Newell Rubbermaid's DYMO® range of products.
  • Acting for Apple Inc in Copyright Tribunal Proceedings relating to setting a reasonable rate for royalties for digital downloads.
  • Acting for Skyscanner, a travel metasearch provider, in proceedings where it was alleged that Skyscanner breached the terms of a licence to a hotels metasearch solution and infringed copyright in that solution.
  • Acting for Minova, part of the Orica group of companies, in relation to a dispute alleging misuse of confidential information, copyright infringement and breach of fiduciary duties.
  • Acting for the Department of Defence in a patent dispute relating to a patent claiming portable aircraft hangars.
  • Acting for Australia Wool Industries in a multijurisdictional dispute in relation to a patent claiming a process of indigo dying of wool.

Regulatory

  • Advising a global biopharmaceutical company on implementing several clinical trial programs across a number of jurisdictions, including Australia, Hong Kong, Taiwan, South Korea, Malaysia and New Zealand.
  • Acting for a top five innovator biopharmaceutical company in successfully challenging a recommendation by PBAC to list a new drug on the PBS on the basis that it was interchangeable on an individual patient basis and was non-inferior to other therapeutically related drugs, thus avoiding a price reduction. 
  • Acting for a global medical device company in a coronial inquest into the death of a patient who was administered an overdose of analgesic via an infusion pump manufactured by that company,
  • Advising a large global medical device company in relation to a review of its regional Healthcare Compliance Policies and rolling out training as part of a compliance program, 
  • Acting for a top five innovator pharmaceutical company in multiple coronial investigations where a temporal link was being investigated between the deceased's consumption of a drug and suicide ideation.
  • Acting for Parnell, an Australia based veterinary pharmaceutical company, in relation to the regulatory due diligence and disclosures associated with its AUD50 million initial public offering on the NASDAQ Global Market.
  • Advising a global medical device company in relation to a complaint made to the TGA's CRP and, subsequently, successfully challenging the CRP's decision. 
  • Advising and acting for a medical device company in a matter where the Therapeutic Goods Administration refused to list a medical device and successfully having the product being listed on an expedited basis. 
  • Advising a US based company setting up retail and online stores on all aspects of Australian food product regulation.
  • Advising a company seeking to market infant formula in Australian on the regulatory framework as well as assisting it devise distribution channels into Asia, particularly China.

Commercialisation

  • Advising NovoNordisk on a strategic global acquisition relating to various intellectual property rights (including patent rights) in respect of a C5A-Recptor inhibitor.
  • Advising a top 10 pharmaceutical company on implementing a global co-promotion agreement with another top 20 pharmaceutical company over a broad range of products.
  • Advising a veterinary pharmaceutical company on issues arising from the global acquisition of another veterinary pharmaceutical company, including advising on contractual issues that arose as a result of that acquisition and the transfer of contractual obligations between the parties. 
  • Advising an Australian university on intellectual property management strategies, including advising on the exploitation, commercialisation, management and protection of its intellectual property rights.